What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 49452/0001.


Solacutan

Package leaflet: Information for the user

Solacutan® 3% gel

diclofenac sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Solacutan gel is and what it is used for
2. What you need to know before you use Solacutan gel
3. How to use Solacutan gel
4. Possible side effects
5. How to store Solacutan gel
6. Contents of the pack and other information

1. WHAT SOLACUTAN GEL IS AND WHAT IT IS USED FOR

Solacutan gel is a non-steroidal antiinflammatory dermatological gel. Solacutan gel is applied to the skin to treat a skin problem known as actinic or solar keratosis that is caused by long-term extensive sun exposure.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLACUTAN GEL

Do not use Solacutan gel

  • if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
  • if you have ever experienced an allergic reaction such as skin rash (nettle rash), breathing problems (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory medicinal products.
  • if you are in the final 3 months of your pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Solacutan gel.

  • The possibility of systemic adverse reactions following application of Solacutan gel cannot be excluded when the medicinal product is used on large areas of skin and for a prolonged period of time. Consult your doctor if you:
    • have, or have had in the past, a stomach ulcer or bleeding from the stomach,
    • have heart, liver or kidney problems,
    • have any type of bleeding disorder or bruise easily.
  • Avoid direct sun exposure and the use of tanning salons when using Solacutan gel. If skin reactions occur, discontinue use of this medicinal product.
  • Do not apply to wounds, infected skin or inflammation of skin.
  • Do not allow Solacutan gel to come into contact with your eyes or the inside (mucosal lining) of your mouth or nose and do not swallow it. If Solacutan gel has accidentally been swallowed, consult a doctor immediately.
  • Discontinue use of Solacutan gel and consult your doctor if you develop a wide-spread skin rash.
  • After applying products containing diclofenac on the skin you can use a permeable (non-occlusive) bandage. Do not use an airtight occlusive dressing.

Children and adolescents

Dosage recommendations and indications for the use of Solacutan have not been established for use in children and adolescents.

Other medicines and Solacutan gel

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, ask your doctor for advice before using Solacutan gel. Solacutan gel should be used with caution during the first six months of pregnancy but it must not be used during the last three months of pregnancy.

Consult your doctor if you are breast-feeding. Solacutan gel can be used with caution whilst breast-feeding but it must not be used on the breasts.

If you are pregnant, planning to have a baby, or breast-feeding, and your doctor considers treatment appropriate, Solacutan gel must not be applied to an area of the skin larger than a third of your body and must not be used for longer than three weeks.

Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and using machines

No specific precautions are necessary.

Solacutan gel contains benzyl alcohol

This medicine contains 15 mg benzyl alcohol per each gram of gel.

Benzyl alcohol may cause allergic reactions and mild local irritation.

3. HOW TO USE SOLACUTAN GEL

  • Solacutan gel is not suitable for children.
  • Always use Solacutan gel exactly as your doctor has told you. Check with your doctor if you are not sure.
  • Pierce the aluminium membrane across the tube opening with the cap before use.
  • Gently spread a small amount of gel onto the skin area to be treated. The amount of gel needed will vary depending on the size of the area to be treated. Usually 0.5 grams of gel (equivalent to about the size of a pea) will be enough for one area (5 cm x 5 cm). However, not more than 8 grams should be used per day.
  • You can apply Solacutan gel twice daily unless your doctor tells you differently. You may notice a slight cooling effect when applying the gel onto your skin.
  • The usual duration of treatment is 60 to 90 days. Maximum effect has been seen with treatment times closer to 90 days. Complete healing may not occur for up to a month after treatment has stopped.
  • Wash your hands after applying the gel unless your hands are being treated.

If you use more Solacutan gel than you should

Remove excess gel by washing with water.

If you forget to use Solacutan gel

Continue to apply as directed but do not apply twice as much to make up for the missed application.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following side effects, stop using Solacutan gel and contact your doctor as soon as possible:

Skin rash (nettle rash), breathing problems (wheezing); swelling of the face; runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solacutan gel.

If any of the following common side effects are severe or last for more than a few days, you should stop using Solacutan gel and contact your doctor: itching, skin rash, skin redness, inflammation, contact dermatitis, pain and blistering.

Other common side effects:

(may affect up to 1 in 10 people)

Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the skin is touched, pins and needles, muscle stiffness, inflammation of the skin, eczema, dry skin, swelling, skin rash (including scaling or blistering), sagging of the skin and skin ulcer.

Uncommon side effects:

(may affect up to 1 in 100 people)

Eye pain, weeping/dry eyes, abdominal pain, diarrhoea, feeling sick, hair loss, facial swelling, excessive bleeding or oily skin, a measles-like skin rash.

Rare side effects:

(may affect up to 1 in 1,000 people)

Skin inflammation with large blisters

Very rare side effects:

(may affect up to 1 in 10,000 people)

Bleeding from your stomach, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including nettle rash, rapid swelling of the skin and mucous membranes), infected skin rash, skin sensitivity to sunlight.

Temporary hair discolouration at the application site has been reported. This is usually reversed after stopping treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SOLACUTAN GEL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Shelf life once opened

Once the tube is opened, Solacutan gel has a shelf life of 6 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Solacutan gel contains

The active substance is:

diclofenac sodium

1 g gel contains 30 mg diclofenac sodium.

The other ingredients are:

sodium hyaluronate; macrogol 400; benzyl alcohol; purified water

What Solacutan gel looks like and contents of the pack

Solacutan gel is a clear, transparent, colourless to yellowish gel and is supplied in aluminium tubes containing 10 g, 25 g, 26 g, 30 g, 50 g, 60 g, or 90 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mibe Pharma UK Ltd
4 Coleman Street
6th Floor
London
EC2R 5AR
United Kingdom

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This leaflet was last revised in August 2019.